Raffinose Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial is currently recruiting pediatric patients with peanut and nut allergies to investigate how an immune-supportive diet incorporating raffinose affects intestinal permeability and clinical symptoms. Classified under a Not Applicable phase, this study is conducted across healthcare institutions and research foundations, including Erasmus Medical Center and Wageningen University. Overall, this research aims to evaluate whether prebiotic oligosaccharide supplementation can restore gastrointestinal mucosal barrier integrity and mitigate systemic allergic reactivity in pediatric food hypersensitivities.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05667610	Recruiting	Peanut Allergy\|Nut Allergy	Onze Lieve Vrouwe Gasthuis\|Ekhaga foundation\|Rijnstate Hospital\|Noordwest Ziekenhuisgroep\|Erasmus Medical Center\|Wageningen University\|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	2022-09-08	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Raffinose product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-digestible trisaccharide, raffinose serves as a prebiotic fermentable substrate for beneficial colonic microflora, driving the production of short-chain fatty acids that reinforce intestinal epithelial tight junctions and regulate mucosal immune homeostasis. Through the maintenance of gut barrier integrity and the attenuation of luminal antigen translocation, this mechanism supports reduced systemic hypersensitivity, which is directly relevant to managing clinical manifestations of peanut allergy and nut allergy.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).